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Diss Factsheets
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EC number: 701-307-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP conform study following guideline 90/385/EWG, 93/42/EWG and DIN EN ISO/IEC 17025 for testing of medical devices.
Data source
Materials and methods
- Type of study / information:
- This ln vitro method analyses the cytotoxic potential of the test item. The test is carried out using the mouse cell line L929 cultured with differentconcentrations of an extract of the test item. The vitality of the cells or potential cytotoxic effects of the extract are registered via the protein content of the cell culture as compared to the controls.
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-1 "Evaluation and testing within a risk management process"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-5 "Tests for in vitro cytotoxicity"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-12 "Sample preparation and reference materials"
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Results and discussion
Any other information on results incl. tables
Test item: Synthetic cubic Boron Nitride Grade 2 (2 micron) Powder
Rel. Protein content (A550) (a) | |||||||
1 | 2 | 3 | x | + | s | Growth inhibition in % | |
Blank | 0.111 | 0.111 | 0.110 | 0.111 | + | 0.000 | |
Positive control (b) | 0.199 | 0.213 | 0.227 | 0.213 | + | 0.011 | 88 |
Negative control (c) | 0.870 | 0.874 | 0.812 | 0.852 | + | 0.028 | 14 |
Solvent control | |||||||
100 % v/v | 0.956 | 0.956 | 0.996 | 0.969 | + | 0.019 | 0 |
66.7 % v/v | 1.024 | 1.035 | 1.037 | 1.032 | + | 0.006 | 0 |
44.4 % v/v | 1.048 | 1.058 | 0.994 | 1.033 | + | 0.028 | 0 |
29.6 % v/v | 0.905 | 0.913 | 0.935 | 0.918 | + | 0.013 | 0 |
19.8 % v/v | 1.060 | 1.018 | 0.993 | 1.024 | + | 0.028 | 0 |
13.2 % v/v | 1.000 | 1.013 | 0.978 | 0.997 | + | 0.014 | 0 |
Test extract (d) | |||||||
100 % v/v | 0.800 | 0.810 | 0.853 | 0.821 | + | 0.023 | 17 |
66.7 % v/v | 0.923 | 0.959 | 0.941 | 0.941 | + | 0.015 | 10 |
44.4 % v/v | 0.993 | 1.037 | 1.039 | 1.023 | + | 0.021 | 1 |
29.6 % v/v | 0.903 | 0.938 | 0.917 | 0.919 | + | 0.014 | 0 |
19.8 % v/v | 1.048 | 1.030 | 1.050 | 1.043 | + | 0.009 | 0 |
13.2 % v/v | 1.022 | 0.987 | 1.020 | 1.010 | + | 0.016 | 0 |
(a) 3 parallel cultures, mean + standard deviation
(b)5% DMSO in DMEM l0% FCS
(c) PE material extracted in DMEM l0% FCS
(d) The test item was extracted under agitation in DMEM l0% FCS for 24 + 2 h at 37 + 1°C and the extract was cultured for 68- 72 h with L929 cells at a final weight/volume ratio of 0.2 g test item / mL culture
The controls confirmed the validity of the study. Cell growth of the positive cultures was inhibited by 88%. The extract of the negative control did not show a relevant inhibition of cell growth (14%).
Applicant's summary and conclusion
- Conclusions:
- In this study under the given conditions no leachable substances were released in cytotoxic concentrations from the test item.
- Executive summary:
In the present study the cytotoxic effects of Synthetic cubic Boron Nitride Grade 2 (2 micron) Powder were analysed. Hereby, the test item was extracted under agitation for 24 t 2 h with cell culture medium and the extract was incubated with L929 cells for 68 - 72 h. The protein content of the individual cultures was then analysed as a measure for cytotoxicity and compared to those of the controls.
In this study under the given conditions no leachable materials were released in cytotoxic concentrations from the test item.
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